Member Info for Ivyspivey

If you read the Powers article it is obvious that his rationale is based he wants better ABs especially vs gram negative bacteria.
He is totally unaware of how Iclaprim was being positioned rather than as a drug of last resort.
If it is was such a hopeless case ask why the following things happened.
Invesco/Standard Life/Aviva/M&G/Sandgrove all invest 19s of millions of £ at averages 6 x the current SP.
Why did the FDA encourage MTFB to develop Iclaprim and suggest the changes to trial protocol to overcome previous concerns.
Plus much more

CFP I specifically said the FDA did not raise concerns about the liver toxicity then that was mentioned by EMA response.
Obviously there is more info required re the CRL and yes the Assist data was submitted as part of NDA but you cannot extrapolate from 2009 and now.
Me and Thoth have totally different views on the history and probable outcome here.Yet we both posted the same link which in know way can be seen as support if MTFB.
However posting any link without attempting to dissect it in a balanced way is hardly imo an informed opinion

Morning.
You cannot compare Iclaprim from the Arpida days to now without taking into account alll the changes since then.
The FDA back then had a number of issues but liver toxicity was not one of them.
The main safety issue ie QTc prolongation is a cardiac issue.This and the efficacy NI issues rsised by the FDA are not mentioned in the CRL so they must be satisfied with the MTFB phase 3 trial results based on the agreed changes to trial protocol.

The comment from the FDA quoted in 2015 is about all QIDP awards to ABs as well other provisions of the GAIN Act.

Iclaprim does not have lots of similar compounds on the market it is a novel DHFR only related to TMP.

We can all make selective quotes whether informed/ intentional or otherwise and I am happy to publish the reference that CFP quotes from but you really need to try and get a fuller understanding of the complete picture which is one of the reasons I don’t slways respond to every question as it usually requires more than a one line response.

http://www.in-pharmatechnologist.com/Regulatory-Safety/FDA-veteran-questions-science-behind-antibiotics-fast-track

Hi MP
Not sure what links you mean apart from the earlier ones tonight at 1726 which are still there about Senator lobbying fees

Bugsy very timely.The last time I heard that a Woman Conservative PM was making the news.
Some things never change.

Howe contested the second ballot of the 1975 Conservative leadership election, in which Margaret Thatcher was elected as party leader. ... In 1978, Healey said that an attack from Howe was "like being savaged by a dead sheep".

The twitterer was a Great Tit otherwise known as a Bot which simply tweets out an payment reference applicable to any US Senator

Coggy as WH Boy says it is what FRR pays for senators to lobby.
These details are from last year but have been tweeted out 3 days ago

http://bit.ly/2TWVib6

http://bit.ly/2TT179n

http://bit.ly/2We0qo3

There were a few reasons why Arpida failed.The efficacy was not good enough and the 2 safety issues were Cardiac ie prolonged QTc and liver issues due to elevated AST and ALT.
Apart from the liver toxicity which the FDA has raised questions on the various changes MTFB made to the trial protocol at the behest and support of FDA seem to have overcome the issues

The exact statement in the CRL RNS is

The CRL states that the FDA cannot approve the NDA in its present form and indicates that additional data are needed to further evaluate the risk for liver toxicity before the NDA may be approved. Motif Bio plans to request a meeting with the FDA as soon as possible to discuss potential options to address the deficiencies.

Not that the FDA should not be developed any further.They are totally different statements and are in no way indicative that Iclaprim will not be Approved at some future stage which has happened with many other compounds.

CFP,
Thanks for response.
First MTFB is essentially a US Company not UK so why would FDA want to protect itself when there is such a desperate need for new ABs and it has been collaborative so far.
As you say all the available data seems to endorse Iclaprim as being safe but obviously the FDA have raised an issue.This imo is likely to be a relatively minor one as opposed to a major one judging by the available evidence.
The CRL would list in detail the exact issue or points it required addressing.However before giving a complete response they would want to make 100% sure that they fully understood and exactly what the FDA required to overcome their concern.

Agree Calamari.
One issue is liver toxicity caused by day elevated enzyme levels.
Points would be raised ALT levels and seoarate point would be raised AST levels for instance

Hi CFP,
Still here just watching and waiting.Just little point in spending hours responding to posts which you know are driven by agendas and designed to clog up the board with repetitive negativity.
Whether you call them points/issues or whatever of course they were contained in the CRL.What else did you expect it to say.
The Arpida information is in the public demain and many on here are fully aware of it.
They won’t disclose the detail of the CRL for 2 reasons one as not to let any potential competitor get any benefit and also out if fear of upsetting the FDA who have a critical influence on the future here.
Your point that the FDA will never Approve Iclaprim is not worth responding to as how can you possibly reach that conclusion based on the available information.Pure scaremongering imo.
Personally think the 2 huge mistakes GL has made are the Nasdaq listing and the failure to have a contingency plan in case of the CRL.
Not sure what you mean by too much opposition here and all conspiracy theory and yes the shorters/ traders / flippers will exploit this situation to the full which is why I have been trading a few around the edges rather than averaging down( same reason as Marineville).
Still have my core holding at much higher average and remain hopeful it will come good but probably a fair wait and obviously lot more dilution.
The FDA meeting is the key event here and yes they have raised enough money until June and the further raise will be the key signal.
Like Ian B.I think the best plan of action is a small raise until they clearly know what the FDA requires and then decide from there tgevosthway forward.

http://cbw.ge/economy/nato-secretary-general-and-prime-minister-discuss-georgias-progress-toward-euro-atlantic-integration/

Thanks very much for explantation and know we don’t have full detail but always good to have a informed opinion.
So you don’t think it is something like simply reducing the amount of damages to zero and the Judge finalising and rubber stamping an OOC

https://www.judicial.ky/wp-content/uploads/courts/grand-court/GrandCourtList25thMarch2019(1).pdf

Oopsi
What is your reading of court appearance and amended summons for half day on 27th.
TIA

Agree totally that a licensing deal will be much better but I believe these will come after assuming “Approval”.
I think the raise will be a small one to get them over the line but who buys will be crucial.If it is flippers like Sabby then nit so good but if existing SH like Invesco that is huge as they need it non dilutive to get average down and a profit but do you really think they would buy their normal 25% unless they had even greater confidence in overcoming the FDA concerns.
Yes they have a lot tied up already but after the CRL the fund manager will want a real due diligence risk assessment of likelihood of Approval and they will be in a much better position to assess exactly how FDA discussions are likely to go and COS

There were the odd comment on here this morning about apparent delay in sorting this out.
It may have appeared so but the comment from today’s RNS may help explain.

that critical personnel from the FDA have been invited to attend the upcoming meeting with our internal and external experts.

So these experts from both sides will often have very packed diaries and be very much in demand for months in advance so that date may have being first available to try and get them all there.

It is critical that all key influencers and decision makers are at this meeting

Not sure about exact protocol but if you look at Preliminary Meeting with Iclaprim

http://www.lse.co.uk/share-regulatory-news.asp?shareprice=MTFB&ArticleCode=spszh7la&ArticleHeadline=FDA_agree_to_enter_clinical_development_programme

Then official minutes came later

http://www.lse.co.uk/share-regulatory-news.asp?shareprice=MTFB&ArticleCode=7fi41lkk&ArticleHeadline=FDA_Meeting_Minutes_Confirming_Iclaprim_Phase_III

Know it us different type of meeting but you may get some general rather than specific feedback re meeting but no certainty